9
Early Postoperative
1. Cardiovascular disorders including venous thrombosis, pulmonary embolism and myocardial
infarction.
2. Hematoma and/or delayed wound healing.
3. Pneumonia and/or atelectasis.
4. Subluxation or dislocation
Late Postoperative
1. Trochanteric avulsion from excessive muscular tension, weight-bearing, or inadvertent
intraoperative weakening of the trochanter.
2. Aggravation of problems in the ipsilateral or contralateral knee and ankle joints due to leg
length discrepancy, femoral medialization and/or muscular deficiencies.
3. Femoral or acetabular fracture due to trauma or excessive loading, particularly in the
presence of poor bone stock caused by severe osteoporosis, bone defects from previous
surgery, intraoperative reaming procedures, or bone resorption.
4. Bone resorption which may contribute to the deterioration of fixation and eventual loosening
of the implant.
5. Periarticular calcification or ossification which may lead to a decrease in joint mobility and
range of motion.
6. Traumatic arthrosis of the ipsilateral knee secondary to intraoperative positioning, of the
extremity during surgery.
7. Subluxation or dislocation.
WARNING: If postoperative breakage or chipping of the ceramic femoral head component is
confirmed, surgery for its removal must be performed as soon as reasonably possible.
HOW SUPPLIED
Femoral stems, femoral heads, acetabular cups, Self-Centering Hip and hemi-hip components
are individually packaged and supplied STERILE. All metal and ceramic components are
sterilized using radiation. UHMWPE components may be sterilized with gas plasma, Ethylene
Oxide (EtO) or radiation, as indicated on the outer package label. Remove from the package
using accepted aseptic technique only after the correct size has been determined.
CAUTION: Prostheses with ceramic coatings CANNOT be re-sterilized. Do not use these
components if the sterile packaging appears damaged.
FRANÇAIS
MODE D'EMPLOI
See product
label for method
ENGLISH
La méthode de stérilisation
figure sur l'étiquette du produit
ATTENTION : Conformément à la loi fédérale des États-Unis, ce dispositif ne peut être
utilisé ou prescrit que par un médecin.
DESCRIPTION DU DISPOSITIF – PROTHÈSE TOTALE DE HANCHE
Une Prothèse totale de hanche se compose d'une tige fémorale en titane (Ti-6AI-4V), d'une tête
fémorale modulaire métallique ou céramique et de composants cotyloïdiens à 2 parties en
polyéthylène à poids moléculaire ultra élevé (UHMWPE) avec renforcement métallique, en
céramique* ou entièrement en UHMWPE, conçus pour remplacer la surface articulaire naturelle
de l’articulation de la hanche et emballés individuellement.
Summary of Contents for ACTIS DUOFIX
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